NCT03083236

Unknown

Parent-based Intervention for Language Delayed 2 to 3 Year O...

Solent NHS Trust Source

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Other study identifiers

Sponsor study identifier

Solent NHS Trust

Study Type

interventional

Estimated enrollment

192

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

March 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

The aim of the study is to evaluate the impact of parent based intervention on the language of 2 to 3 year old children from socially disadvantaged populations with a clinical diagnosis of primary language delay.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 192 participants
Study completion date: March 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 8, 2017
Actual (reported)
First Posted
March 17, 2017
Actual (reported)
Study Start
October 2017
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: October 10, 2017
Status Verified: October 2017
Last Update Submitted: October 9, 2017

Conditions

Speech and Language Therapy

Outcome Measures

Primary Outcomes (1)

The Pre-School Language Scales 5 UK (PLS 5 UK)
The planned primary outcome measure for the proposed RCT is a quantitative measure of child language using a standardised assessment measure, The Pre-School Language Scales 5 UK (PLS 5 UK) (Zimmerman et al, 2014). This will provide a sound measure of reliability and validity.
2 years

Interventions

Standard PBIOther

Standard Parent Based Intervention (PBI)

EnhancedOther

Enhanced Parent Based Intervention (EPBI)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age24 Months - 36 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

The child is 24-36 months old
The child has little or no expressive language (a vocabulary of 40 or less single words)

Sponsors & Collaborators

Solent NHS Trust
Governmentlead

MeSH Terms

Conditions

Communication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 17, 2017

Study Start

October 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

March 2020

Estimated (date passed)

The child has no known aetiology; the language delay is not secondary to sensory, structural, neurological or cognitive impairments

The family have been assessed as having low socioeconomic status The study will use the Index of Multiple Deprivation (IMD) as a basis to determining a measure of deprivation. The IMD combines information from seven domains (income, employment, education, health, crime, housing and living environment) to produce an overall measure and it ranks how deprived areas are relative to others. This will be used to determine which areas and Children's Centres will be involved in the proposed RCT. However, as this is a geographical ranking, the RCT will include further refinement of eligibility of social disadvantage via assessment of individual measures of income deprivation, employment deprivation and education attainment. This information on employment and parent education levels will be collected via the case history taken at the initial assessment, as this is standard practice in a profile of risk for child language delay. The additional information on income will be taken at the first research assessment, as this does not form part of standard practice

You may not qualify if:

The child's expressive language consists of a vocabulary of more than 40 single words
The child's language delay is secondary to sensory, structural, neurological or cognitive impairments
English is not the first language for the family.
Where English is not the first language, children would be excluded. Adjustments to the protocol and delivery of intervention would be required where English is an additional language (EAL) and there is a need to test the intervention first on an English-speaking population. If effective, a longer term programme plan would be to amend the programme and evaluate the effectiveness with EAL children.

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

October 10, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT03083236
Data provider: ClinicalTrials.gov
Source updated: 2017-10-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:36 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record